SepsisNCT01801501
Role of FGF-23 as a Prognosis Biomarker in Intensive Care Patients
An observational study of Sepsis and Acute Kidney Injury, run by University of Chile at 1 site in Chile.
Trial summary
The purpose of the study is to evaluate the potential role of plasmatic Fibroblast Growth Factor 23 (FGF-23) as a prognosis predictor of clinical outcomes in Critical Care patients. Read more about this study
- Who is it for?
- Ages 15 to 89 years
- Conditions the study is for
- Sepsis, Acute Kidney Injury
- How many people
- 164 participants
- Where
- 1 siteChile
- Study dates
- Jan 2012to Dec 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted in Critical Care Unit with diagnosis of severe sepsis/septic shock. Pregnant women and transplanted patients are excluded.
Who may be able to join
- Admission in Critical Care Unit
- Sepsis
Who cannot join
- Pregnancy
- Organ transplantation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the potential role of plasmatic Fibroblast Growth Factor 23 (FGF-23) as a prognosis predictor of clinical outcomes in Critical Care patients.
Read the detailed description
Observational study of patients admitted in the Critical Care Unit (CCU) of University of Chile Clinical Hospital, admitted with diagnosis of severe sepsis/septic shock.
Exclusion criteria: Pregnancy, organ transplantation. Informed consent is solicited to patients before admission in study. If the patient cannot give it because of his/her clinical condition, it will be solicited to a patient representative.
After admission in CCU and achievement of informed consent, a venous blood sample will be obtained, to determinate plasmatic levels of Fibroblast Growth Factor 23 (FGF-23). New samples will be obtained at 24 and 48 hours after admission. Determination of FGF-23 will be performed by ELISA technique in Integrated Physiology laboratory.
Demographics, clinical and biochemical data will also be obtained. The data will be collected by the Principal Investigator. Confidentially of all data will be preserved during and after the completion of the study.
The study is divided in 2 parts:
- - Evaluation of a sample of 14 patients to determinate the impact of FGF-23 to predict presence and severity of Acute Kidney Injury (AKI), and to estimate sample size to predict primary outcomes.
- - Evaluation of a larger sample, to determinate the impact of FGF-23 to predict primary outcomes.
Primary outcomes:
- - Development of acute kidney injury
- - Severity of AKI, determinate by AKIN classification
- - In-hospital mortality
Secondary outcomes:
- - Requirements of renal replacement therapy
- - Requirements of mechanical ventilation
- - Requirements of vasoactive drugs
- - Duration of ICU stay and hospital stay
As a post-hoc analysis, we performed a measurement of a combined biomarker, including FGF-23 and other 2 biomarkers, Klotho and Erythropoietin, measured in blood samples, to determinate its predictive capacity for AKI diagnosis and mortality.
The protocol was approved by the Ethical Committee of University of Chile Clinical Hospital. The study is monitored by the Clinical Investigation Support Office (OAIC) of the hospital.
- Conditions
- Sepsis, Acute Kidney Injury
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critical Care Patients | Patients admitted in Critical Care Unit with diagnosis of severe sepsis/septic shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Determination of overall survival during the first 30 days and 1 year after admission
Measured: 30 days and 1 year
Secondary outcomes (1)
Duration of hospitalization
Determination of number of days of hospitalization (in ICU and overall hospitalization)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Toro, University of Chile
- Investigators
- Luis Toro, MD, Principal investigator, University of Chile Clinical HospitalLuis Michea, MD PhD, Principal investigator, University of ChileCarlos Romero, MD, Study chair, University of Chile Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801501
- Sponsor's protocol ID
- AKI-FGF23-012
- Status last verified
- May 2020
- First submitted
- 25 Feb 2013
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of FGF-23 as a Prognosis Biomarker in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT01801501
- Acronym / sponsor ID
- AKI-FGF23-012
- Conditions
- Sepsis, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the potential role of plasmatic Fibroblast Growth Factor 23 (FGF-23) as a prognosis predictor of clinical outcomes in Critical Care patients.
Detailed description
Observational study of patients admitted in the Critical Care Unit (CCU) of University of Chile Clinical Hospital, admitted with diagnosis of severe sepsis/septic shock.
Exclusion criteria: Pregnancy, organ transplantation. Informed consent is solicited to patients before admission in study. If the patient cannot give it because of his/her clinical condition, it will be solicited to a patient representative.
After admission in CCU and achievement of informed consent, a venous blood sample will be obtained, to determinate plasmatic levels of Fibroblast Growth Factor 23 (FGF-23). New samples will be obtained at 24 and 48 hours after admission. Determination of FGF-23 will be performed by ELISA technique in Integrated Physiology laboratory.
Demographics, clinical and biochemical data will also be obtained. The data will be collected by the Principal Investigator. Confidentially of all data will be preserved during and after the completion of the study.
The study is divided in 2 parts:
- - Evaluation of a sample of 14 patients to determinate the impact of FGF-23 to predict presence and severity of Acute Kidney Injury (AKI), and to estimate sample size to predict primary outcomes.
- - Evaluation of a larger sample, to determinate the impact of FGF-23 to predict primary outcomes.
Primary outcomes:
- - Development of acute kidney injury
- - Severity of AKI, determinate by AKIN classification
- - In-hospital mortality
Secondary outcomes:
- - Requirements of renal replacement therapy
- - Requirements of mechanical ventilation
- - Requirements of vasoactive drugs
- - Duration of ICU stay and hospital stay
As a post-hoc analysis, we performed a measurement of a combined biomarker, including FGF-23 and other 2 biomarkers, Klotho and Erythropoietin, measured in blood samples, to determinate its predictive capacity for AKI diagnosis and mortality.
The protocol was approved by the Ethical Committee of University of Chile Clinical Hospital. The study is monitored by the Clinical Investigation Support Office (OAIC) of the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical Care Patients | – | –Patients admitted in Critical Care Unit with diagnosis of severe sepsis/septic shock |
Who may qualify
- Ages
- 15 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted in Critical Care Unit with diagnosis of severe sepsis/septic shock. Pregnant women and transplanted patients are excluded.
Key inclusion criteria (2 listed)
- Admission in Critical Care Unit
- Sepsis
Key exclusion criteria (2 listed)
- Pregnancy
- Organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 30 days and 1 year
Determination of overall survival during the first 30 days and 1 year after admission
1 secondary outcome
Duration of hospitalization
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Toro, MD principal investigator
University of Chile Clinical Hospital
Luis Michea, MD PhD principal investigator
University of Chile
Carlos Romero, MD study chair
University of Chile Clinical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Acute Kidney Injury, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 30 days and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.